Scientist

Fresenius Kabi•Melrose Park, IL

29d

About The Position

Accepts responsibility for all aspects of Analytical Development, including raw material release, stability, and formulation testing, etc. Performs validations or verification of methods including transfer of methods to Quality Technologies or Quality Control or other testing laboratory. Review and approve Validation protocol/report, data packages, SOPs and other Laboratory documentation. Manages stability program by execution of stability testing protocols, testing logistics for laboratory, providing stability summaries, finished product COA generation and provides updates to Regulatory Affairs and project team. Support Laboratory operation for instrument qualification. Ensures all technologies needed are available for project completion. Plans, develops, and implements scientifically well-designed experimental programs and demonstrates creativity and capability in analytical method development, validation, and testing. Identifies problem areas and utilizes scientific resources to recommend alternatives, priorities, and results to resolve problems. Accurately and completely records experimental procedures, test results, and observations to meet corporate and GMP requirements. Establishes work priorities for assignments within his/her authority and keeps assignment completion on schedule. Requires an eye for detail and repetitive precision in lab work and documentation. Fresenius Kabi (www.fresenius-kabi.com) is a global health care company that specializes in injectable medicines, biosimilars, and technologies for infusion, transfusion, and clinical nutrition. Our expansive portfolio of products and global network of science and manufacturing centers provide essential support for the care of critical and chronically ill patients. With more than 40,000 employees working in 60 countries, our dedicated team is united by our shared purpose: to put lifesaving medicines and technologies in the hands of people who care for patients - and to find answers to the challenges they face. We call this purpose committed to life. We are proud to be part of the Fresenius Group with its more than 190,000 employees worldwide. Everyday, we use our dedication, expertise, and passion to help advance healthcare opportunities and make a difference in people’s lives everywhere. Follow us on Linkedin to learn more.

Responsibilities

Accepts responsibility for all aspects of Analytical Development, including raw material release, stability, and formulation testing, etc.
Performs validations or verification of methods including transfer of methods to Quality Technologies or Quality Control or other testing laboratory.
Review and approve Validation protocol/report, data packages, SOPs and other Laboratory documentation.
Manages stability program by execution of stability testing protocols, testing logistics for laboratory, providing stability summaries, finished product COA generation and provides updates to Regulatory Affairs and project team.
Support Laboratory operation for instrument qualification.
Ensures all technologies needed are available for project completion.
Plans, develops, and implements scientifically well-designed experimental programs and demonstrates creativity and capability in analytical method development, validation, and testing.
Identifies problem areas and utilizes scientific resources to recommend alternatives, priorities, and results to resolve problems.
Accurately and completely records experimental procedures, test results, and observations to meet corporate and GMP requirements.
Establishes work priorities for assignments within his/her authority and keeps assignment completion on schedule.
Requires an eye for detail and repetitive precision in lab work and documentation.